U.S. patent number 10,485,528 [Application Number 14/615,241] was granted by the patent office on 2019-11-26 for individual packaging arrangement for orthopedic tools.
This patent grant is currently assigned to Spinal Generations, LLC. The grantee listed for this patent is Spinal Generations, LLC. Invention is credited to Patrick J. Sweeney.
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United States Patent |
10,485,528 |
Sweeney |
November 26, 2019 |
Individual packaging arrangement for orthopedic tools
Abstract
A protective member for a medical instrument includes a body
portion having an inner side wall defining an interior, configured
to receive at least a portion of the medical instrument. The body
portion also includes a first end and a second end, wherein at
least one of the first end and the second end is configured to at
least partially close the respective first end and/or second end of
the body portion. The at least partially closed first end and/or
second end is configured to be opened for use of the medical
instrument, such that the medical instrument can pass through both
the first and second ends of the body portion during use, while the
inner side wall surrounds a portion of the medical instrument. The
body portion is configured for use during a medical procedure using
the medical instrument, for example, as a tissue protector or a
drilling guide.
Inventors: |
Sweeney; Patrick J. (Flossmoor,
IL) |
Applicant: |
Name |
City |
State |
Country |
Type |
Spinal Generations, LLC |
Mokena |
IL |
US |
|
|
Assignee: |
Spinal Generations, LLC
(Mokena, IL)
|
Family
ID: |
55349986 |
Appl.
No.: |
14/615,241 |
Filed: |
February 5, 2015 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20160228188 A1 |
Aug 11, 2016 |
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
90/90 (20160201); A61B 50/30 (20160201); A61B
17/3494 (20130101); A61B 90/94 (20160201); A61B
50/20 (20160201); A61B 17/02 (20130101); A61B
17/17 (20130101); A61B 17/865 (20130101); A61B
90/98 (20160201); A61B 90/96 (20160201); A61B
2017/00889 (20130101); A61B 2050/002 (20160201); A61B
2050/3008 (20160201); A61B 2050/006 (20160201); A61B
2090/062 (20160201); A61B 2050/0054 (20160201); A61B
2050/0065 (20160201); A61B 2090/08021 (20160201); A61B
2050/005 (20160201); A61B 2090/037 (20160201); A61B
2050/0058 (20160201) |
Current International
Class: |
A61B
17/02 (20060101); A61B 17/86 (20060101); A61B
90/94 (20160101); A61B 90/98 (20160101); A61B
17/17 (20060101); A61B 17/34 (20060101); A61B
50/20 (20160101); A61B 50/30 (20160101); A61B
90/90 (20160101); A61B 17/00 (20060101); A61B
90/96 (20160101); A61B 90/00 (20160101); A61B
50/00 (20160101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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|
|
|
|
|
|
WO-00/07510 |
|
Feb 2000 |
|
WO |
|
WO-2005/053753 |
|
Jun 2005 |
|
WO |
|
WO-2010/011985 |
|
Jan 2010 |
|
WO |
|
WO-2015/017677 |
|
Feb 2015 |
|
WO |
|
Other References
International Search Report and Written Opinion for PCT Application
No. PCT/US2016/015731, dated Apr. 8, 2016, 18 pages. cited by
applicant.
|
Primary Examiner: Robert; Eduardo C
Assistant Examiner: Eckman; Michelle C
Attorney, Agent or Firm: Foley & Lardner LLP
Claims
What is claimed is:
1. A medical kit, comprising: a package contoured to receive an
orthopedic tool in a protective member; an outer layer configured
to contain the package so as to maintain sterility of the
orthopedic tool; and the protective member for accommodating the
orthopedic tool and configured to prevent the orthopedic tool from
puncturing the outer layer, the protective member comprising: a
body portion comprising an inner side wall, the inner side wall
defining an interior configured to receive at least a portion of
the orthopedic tool; the body portion further comprising a first
end and a second end, wherein at least one of the first end and the
second end comprises a closed end configured to at least partially
close the respective first end and/or second end of the body
portion; wherein the body portion is collapsed inward at the closed
end such that the closed end is formed by a tapered portion of the
side wall wherein a diameter of the interior decreases until a
first portion of the inner side wall is in contact with a second
portion of the inner side wall, oppositely disposed from the first
portion, to at least partially close the first end and/or second
end and, wherein the closed end is deformable to an open position
for passage of the orthopedic tool therethrough, wherein in the
open position the body portion takes on a tubular shape; wherein
the body portion is configured to deform to the open position for
use of the orthopedic tool, such that the orthopedic tool can pass
through both the first and second ends of the body portion during
use of the orthopedic tool while the inner side wall surrounds a
portion of the orthopedic tool; and wherein the body portion is
configured for use during a medical procedure using the orthopedic
tool.
2. The protective member of claim 1, wherein the side walls forming
the closed end are held together by adhesive.
3. The protective member of claim 1, wherein the orthopedic tool is
completely received within the interior of the body portion.
4. The protective member of claim 1, wherein the body portion is
deformable from the open position to the closed position by
pinching the end wall of the first end and/or second end.
5. The protective member of claim 1, wherein when the body portion
is in the closed position, the closed first end and/or second end
prevents the orthopedic tool received within the interior from
advancing out of the closed respective first end and/or second end
until the orthopedic tool is used.
6. The protective member of claim 1, wherein the side walls forming
the closed first end and/or second end are configured to completely
close the respective first end and/or second end.
7. The protective member of claim 1, wherein the side walls forming
the closed end are held together by heat staking.
8. The protective member of claim 1, wherein the body portion is
deformable from the closed position to the open position by driving
the orthopedic tool through the closed first end and/or second
end.
9. The protective member of claim 1, wherein the body portion is
configured to protect tissue of a patient during the use of the
orthopedic tool.
10. The protective member of claim 1, wherein the first and second
portions of the side wall are held together by adhesive, heat
staking, or a combination thereof.
Description
BACKGROUND
To be safe and effective, medical instruments, such as surgical
tools, must be provided to an operating room undamaged and
sterilized (e.g., free from contamination from foreign substances
or organisms). Surgical tools are sterilized prior to use using a
variety of different processes, including steam sterilization,
chemical sterilization, and radiation sterilization. Surgical tools
may be cleaned sterilized after being used. However, to avoid the
costs associated with cleaning and sterilizing surgical tools,
single-use, disposable surgical tools may be used. Such disposable
surgical tools are sterilized by the manufacturer and provided in a
kit.
To maintain sterility, the surgical tools may be sealed in sterile
packaging for transport and storage. Some surgical tools, such as
blades, gouges, or other cutting instruments may have tips or edges
that need to be kept sharp. These tips or edges could be damaged
during transport or storage. Additionally, such instruments could
potentially damage the packaging in which they are stored and
transported, compromising the sterility of the instruments. Some
tools may, therefore, be packaged with a protector, such as a
silicone sheath slipped over a sharp edge or point. The protector
serves both to protect the sharp edges or points from damage and to
protect the packaging from being damaged by the sharp edges or
points.
Kits containing surgical tools may include tools such as drilling
guides and tissue protectors that are configured to provide a
passage through which other tools are passed. While necessary for
many medical procedures, these tools are often separate from the
active surgical tools and represent additional bulk for an
inclusive kit.
SUMMARY
One embodiment of the invention relates to a protective member for
a medical instrument including a body portion comprising an inner
side wall, the inner side wall defining an interior configured to
receive at least a portion of the medical instrument. The body
portion includes a first end and a second end, wherein at least one
of the first end and the second end comprises an end wall coupled
to the side wall and configured to at least partially close the
respective first end and/or second end of the body portion. The at
least partially closed first end and/or second end of the body
portion is configured to be opened for use of the medical
instrument, such that the medical instrument can pass through both
the first and second ends of the body portion during use of the
medical instrument while the inner side wall surrounds a portion of
the medical instrument. The body portion is configured for use
during a medical procedure using the medical instrument.
In some embodiments, the partially closed first end and/or second
end of the body portion is separable from the body portion to form
a second body portion separate from a main body portion. In certain
such embodiments, the side wall comprises a frangible section
separating the second body portion from the main body portion. In
other embodiments, the second body portion is coupled to the main
body portion at a joint. The joint may be one of a threaded joint,
a sleeve joint, and a snap-fit joint.
In some embodiments, the medical instrument is completely received
within the interior of the body portion. An outer side wall of the
body portion may include a plurality of measurement markings
disposed on an exterior surface. The protective member may include
an identification device. The identification device may be one of a
bar code and a radio-frequency identification device. A portion of
the body portion may be configured for use as a tissue protector or
as a drilling guide. In some embodiments, a portion of the body
portion is configured to remain with the medical instrument and be
implanted into a patient. In some such embodiments, the portion of
the body portion includes an antibacterial material.
A second exemplary embodiment of the invention relates to a method
for protecting tissue during a medical procedure. Prior to the
medical procedure, the method includes obtaining a medical
instrument packaged in and at least partially surrounded by a
protective member, wherein the protective member comprises at least
one partially closed end portion. During the medical procedure, the
method includes opening the at least one partially closed end
portion to form a tubular member. The method further includes
fixing the tubular member proximate tissue at an incision location
to provide a passage of the medical instrument through the tissue
to an area of interest, and passing an end of the medical
instrument through the open tubular member to the area of
interest.
In some embodiments, opening the at least one partially closed end
portion includes separating the closed end portion from the
protective member. In some embodiments, the protective member acts
as a drilling guide to guide the medical instrument to a target
position. Accordingly, the tubular member may be fixed at a desired
orientation such that the medical instrument passes through the
tubular member at the desired orientation. In some embodiments, the
method includes positioning the medical instrument into a desired
final position and leaving the tubular member attached to the
medical instrument and implanted in a body.
A third exemplary embodiment relates to a medical procedure kit
including a plurality of medical instruments and a protective
member containing at least a portion of one of the plurality of
medical instruments. The protective member includes a body portion
comprising an inner side wall, the inner side wall defining an
interior configured to receive at least a portion of the medical
instrument. The body portion further includes a first end and a
second end, wherein at least one of the first end and the second
end comprises an end wall coupled to the side wall and configured
to at least partially close the respective first end and/or second
end of the body portion. The at least partially closed first end
and/or second end of the body portion is configured to be opened
for use of the medical instrument, such that the medical instrument
can pass through both the first and second ends of the body portion
during use of the medical instrument while the inner side wall
surrounds a portion of the medical instrument. The body portion is
configured for use during a medical procedure using the medical
instrument. The body portion of the protective device may be
configured for use as a tissue protector. The body portion of the
protective device may be configured for use as a drilling
guide.
Alternative exemplary embodiments relate to other features and
combinations of features as may be generally recited in the
claims.
BRIEF DESCRIPTION OF THE DRAWINGS
The disclosure will become more fully understood from the following
detailed description, taken in conjunction with the accompanying
figures.
FIG. 1 is a top view of a surgical kit containing a plurality of
orthopedic tools packaged in individual protective members,
according to an exemplary embodiment.
FIG. 2A is a top view of an individual protective member containing
an orthopedic tool, according to an exemplary embodiment.
FIG. 2B is a top view of the protective member of FIG. 2A, opened
to allow the orthopedic tool to be accessed.
FIG. 3A is a top view of an individual protective member containing
an orthopedic tool, according to another exemplary embodiment.
FIG. 3B is a top view of the protective member of FIG. 3A, opened
to allow the orthopedic tool to be accessed.
FIG. 4 is a perspective view of the protective member of FIG. 2A,
including measurement markings, according to an exemplary
embodiment.
FIG. 5 is a perspective view of the protective member of FIG. 2A,
including an identification device, according to an exemplary
embodiment.
FIG. 6 is a perspective view of the protective member of FIG. 2A
utilized as a tissue protector, according to an exemplary
embodiment.
FIG. 7 is a cross-section view of the protective member of FIG. 2A
utilized as a drill guide, according to an exemplary
embodiment.
FIG. 8 is a perspective view of a portion of a protective member
coupled to a bone screw, according to an exemplary embodiment.
FIG. 9A is a partial cross-section view of a protective member
coupled to a bone screw, according to an exemplary embodiment.
FIG. 9B is a partial cross-section view of the bone screw and
protective member of FIG. 9A with the bone screw partially extended
out of the protective member.
FIG. 10A is a partial cross-section view of a protective member
coupled to a bone screw, according to an exemplary embodiment.
FIG. 10B is a partial cross-section view of the bone screw and
protective member of FIG. 10A with the bone screw partially
extended out of the protective member.
FIG. 11 is a schematic view of a system of nested tools and
protective members, according to an exemplary embodiment.
DETAILED DESCRIPTION
Before turning to the figures, which illustrate the exemplary
embodiments in detail, it should be understood that the present
application is not limited to the details or methodology set forth
in the description or illustrated in the figures. It should also be
understood that the terminology is for the purpose of description
only and should not be regarded as limiting.
Referring to FIG. 1, a surgical kit 10 is shown according to an
exemplary embodiment. The kit 10 includes one or more tools 12 in a
package. The tools 12 may be any suitable surgical or other medical
tool that is intended to be sterilized and maintained in a
sterilized environment until use, including, but not limited to
drills, gouges, saws, nails, screws, guide wires, hooks, blades,
clamps, needles, guides, tissue protectors, pins, handles,
fixtures, etc. The tools 12 may be formed from any material that is
suitable for interacting with biological tissues, such as a metal
and metal alloys (e.g., stainless steel, titanium, tungsten
carbide, etc.), or a polymer material (e.g., high density
polyethylene (HDPE), polycarbonate, polyphenyl-sulfone (PPSF),
nylon, etc.), composite materials (e.g., carbon-fiber reinforced
polymers, fiberglass reinforced polymers, etc.), or a combination
of materials.
The tool 12 may, for example, be a fastener, such as a screw,
intended to engage a bone of a patient. The screw may be
self-drilling or may be received in a hole that is predrilled with
a drill bit. The screw may be fully cannulated, partially
cannulated or solid. The kit may include additional tools for use
with the screw, such as a guidewire and a drill bit configured to
pre-drill a hole in a bone to receive the screw.
A plurality of single use orthopedic tools (e.g., disposable tools)
may be provided in a package, such as a sealed pouch, as a part of
a kit for a medical procedure. Each of the tools may be at least
partially sheathed or contained by a protective member. The
protective member protects the orthopedic tool from damage and
protect the package from being punctured or otherwise damaged by
the orthopedic tools. Additionally, the protective members may
serve an additional function as a tissue protector or a drill
guide.
According to an exemplary embodiment, the package for the kit 10
includes an inner member, shown as a tray 14, and an outer member,
shown as a pouch 16. The tray 14 may be a rigid container that is
contoured to receive the individual tools 12. The pouch 16
encapsulates the tools 12 and the tray 14. The tray 14 and/or the
pouch 16 may be sealed to maintain the sterility of the tools 12
until the tools 12 are utilized for a surgical procedure.
The tray 14 and the pouch 16 may be formed from materials and by
methods that are known in the art for the sterile packaging of
medical devices. The tray 14 may be formed from any material that
is suitable for maintaining sterility of the tools 12, such as a
metal or metal alloy (e.g., stainless steel, etc.), or a polymer
material (e.g., HDPE, acrylonitrile butadiene styrene (ABS), etc.).
A removable sealing member, such as a film or membrane may be
coupled to the tray 14 to provide a microbial barrier to maintain
the sterility of the tools 12. The sealing membrane may be formed
from a suitable, plastic material. The pouch 16 may be formed from
a puncture-resistant material, such as a polymer film (e.g., high
density polyethylene), medical grade paper, or a laminate of
multiple materials. The pouch 16 may be sealed and configured to
resist the penetration of microbes from the outside environment
into the interior of the package to maintain the sterility of the
tools 12. The kit 10 may be sterilized with any suitable method,
including ethylene oxide (EO), gamma, electron-beam, steam (under
controlled conditions) and low-temperature oxidative sterilization
processes.
Information concerning the tools 12 may be provided on the tray 14
and/or the pouch 16. The information may be provided in the form of
a graphic or label applied to the tray 14 and/or the pouch 16. The
information may include, for example, the manufacturer, the
distributor, the surgical indications, warnings, directions for
opening, the tools 12 contained in the kit 10, etc.
By providing the tools 12 in the disposable kit 10, preparation
execution of the medical procedure can be simplified by eliminating
the need to clean and reprocess instruments prior to every
procedure. Disposable, single procedure tools 12 minimize the risk
of infection due to cross contamination. For example, the kit 10
may be assembled and sterilized at a manufacturer and then
transported to a care facility, where it may be stored prior to
use. When needed for surgical procedure, the kit 10 may be opened
to provide the sterile tools 10 to the caregiver. The kit 10, as
described in more detail below, is configured to be a relatively
compact unit, thereby reducing storage and transportation cost and
volume.
Referring now to FIGS. 2A-2B, at least one of the tools 12 may be
individually packaged in a protective member, shown as a tube 20
(e.g., sleeve, container, sheath, cover, etc.). The tube 20
includes a side wall 22 that surrounds at least a portion of the
tool 12 (e.g., a pointed or sharp portion of the tool 12) and an
end wall 24 that closes an open end of the tube 20. The tube 20 may
be closed at one or both ends and may partially or completely
enclose the tool 12. The tube 20 may include a graphic, printed
label, or other indicia to indicate the identification and
characteristics of the tool 12 contained inside the tube 20. In
some embodiments, the tube 20 may be color-coded to indicate the
identification and characteristics of the tool 12 contained inside
the tube 20.
In one embodiment, the tube 20 may be generally cylindrical with a
circular cross-sectional shape. In another embodiment, the tube may
have another cross-sectional shape (e.g., ovoid, ellipsoid,
hexagonal, octagonal, etc.) that provides an exterior surface free
of sharp edges or corners that are likely to damage the tray 14
and/or the pouch 16. The tube 20 may have a generally constant
cross-section along its length, as shown in FIGS. 2A and 2B or may
have a variable cross-section (e.g., flared or tapered). The tube
20 may have outwardly or inwardly extending features, such as
ridges or flanges, to accomplish engagement with any separate items
or to hold a tool 12 within the tube.
The tube 20 is a hollow, rigid body that is receives at least a
portion the tool 12. While the tools 12 may have sharp and/or
pointed portions that could potentially damage the tray 14 and/or
the pouch 16, the tube 20 is configured to provide a relatively
smooth exterior that is free of sharp edges or points and that is
less likely to damage the tray 14 and/or the pouch 16. The interior
surface of the tube 20 may include features, (e.g., ribs, ridges,
flanges, protrusions, etc.) configured to stabilize or otherwise
contact the tool 12.
The tube 20 may be formed from any material that substantially
protects the tool 12 from damage, such as during transport or
handling, and is resistant to being punctured or cut by the tool
12. Because the tube 20 may be utilized as an assistive instrument
in a medical procedure, the tube 20 is preferably formed from a
biocompatible material. According to an exemplary embodiment, the
tube 20 is formed from a metal or metal alloy (e.g., stainless
steel, titanium, etc.), a rigid polymer material (e.g., high
density polyethylene (HDPE), polycarbonate, polyphenyl-sulfone
(PPSF), nylon, PEEK, etc.), composite materials (e.g., carbon-fiber
reinforced polymers, fiberglass reinforced polymers, etc.), or a
combination of materials.
The tube 20 may be separable into multiple portions. For example,
the tube 20 may be a substantially closed body and may be
configured to be opened to allow the tool 12 to be removed from the
interior of the tube 20, or slid within to the tube 20. As shown in
FIGS. 2A-3B, the tube 20 may include a first portion 26 and a
second portion 28 that may be separated from each other. In other
embodiments, the tube may have three or more portions (e.g., a
central portion and two end portions).
Referring still to FIGS. 2A-2B, according to an exemplary
embodiment, the tube 20 may include a frangible section 25 at which
a first portion 26 of the tube 20 may be removed from a second
portion 28. The first portion 26 and the second portion 28 may be
formed as a single unitary body and the frangible section 25 may be
a section of the tube 20 at which the side wall 22 is weakened,
such as by being scored or perforated. After being separated at the
frangible section 25, the tube 20 may be removed from the tool 12.
Alternatively, the first portion 26 and/or the second portion 28 of
the tube 20 may be utilized as an assistive instrument in the
medical procedure, as described below.
Referring now to FIGS. 3A-3B, in another embodiment, the first
portion 26 and the second portion 28 of the tube 20 may be
separately formed and may be removably coupled together at a joint
30. According to an exemplary embodiment, the joint 30 is a
threaded joint and the first portion 26 is removed from the second
portion 28 by rotating the first portion 26 and the second portion
28 relative to each other. In another embodiment, the joint 30 may
be another type of joint, such as a sleeve-type joint, or a snap
fit joint. After being separated at the joint 30, the tube 20 may
be removed from the tool 12. Alternatively, the first portion 26
and/or the second portion 28 of the tube 20 may be utilized as an
instrument in the medical procedure, as described below.
Referring now to FIG. 4, the tube 20 may include additional
markings 32 or other measurement features. According to an
exemplary embodiment, the tube 20 may include markings 32 disposed
on the exterior of the side wall 22. The markings 32 may be used to
determine depth measurements when used as a tissue protector or
guide during the medical procedure and/or to determine lengths of
fasteners, such as screws, or other tools housed within the tube
20. Characteristics (e.g., thickness, length, color, etc.) of the
markings 32 may vary to facilitate the reading of a measurement
from a datum, such as the end of the tube 20 or the tube portion on
which the markings 32 are disposed. For example, centimeters and
millimeters may be indicated with different styles of markings 32.
According to another embodiment, the tube 20 may include one or
more slots to indicate distances from a datum.
Referring to FIG. 5, the tube 20 may include an identification
feature 34, shown schematically. The identification feature 34 may
be utilized to track and identify the tube 20 and the tool 12
contained within the tube 20, such as when shipping the kit 10 from
one location to another, for inventory at a location, or to
identify the correct tool 12 needed for a particular procedure. The
identification feature 34 may be located anywhere on the tube 20.
According to one exemplary embodiment, the identification feature
32 may be a bar code or other indicator printed on the outer
surface of the tube 20. According to another exemplary embodiment,
the identification feature 32 may be an electronic device, such as
a radio-frequency identification (RFID) tag coupled to the tube 20.
Such an RFID tag may be disposed on the interior surface of the
tube 20 or on the exterior surface of the tube 20. Although only a
single identification feature 34 is shown in FIG. 5, the tube 20
may include multiple identification features disposed in various
locations.
Referring now to FIG. 6, in one embodiment, a portion of the tube
20 may be utilized as a tissue protector 50 after the tool 12 has
been removed from the tube 20 or the tube 20 manipulated to expose
the working end of the tool 12. For example, the end portions of a
tube 20 may be removed as described above, with a central portion
of the tube 20 being utilized as the tissue protector 50. The
tissue protector 50 is a hollow body that is disposed in the area
of the medical procedure. The tissue protector 50 provides a
passage through which a tool 10 (e.g., a drill bit, screw, gouge,
blade, etc.) may pass to an area of interest, such as a portion of
bone or other subcutaneous structure. The tissue protector 50
protects surrounding tissue (e.g., skin, subcutaneous structures,
etc.) from damage by the tool 12 due to inadvertent contact, such
as when inserting, using, or retracting the tool 12. Accordingly,
tube 20 utilized as tissue protector 50 is configured to have a
similar diameter to the tool 12 being stored therein. For example,
the diameter of the tube 20 may have a diameter slightly larger
than a screw being positioned in the body. In other embodiments,
the diameter may be large enough to accommodate a screw driver that
is providing assistance in positioning the screw in the body. The
tissue protector 50 may be held in the desired orientation by
medical personnel via a handle. The handle may be provided as a
part of the kit 10 and may be removably coupled to the tissue
protector 50 (e.g., via a threaded connection, via a clamp, etc.).
In other embodiments, the handle may be a device such as a hemostat
or other medical clamp. In other exemplary embodiments, the tissue
protector 50 may be held in the desired orientation directly by the
medical personnel or via a stationary brace or fixture that is
fixed in relation to the patient.
Referring now to FIG. 7, in one embodiment, a portion of the tube
20 may be utilized as a drilling guide 40 after the tool 12 has
been removed from the tube 20 or the tube 20 moved to expose the
working end of the tool 12. For example, the end portions of a tube
20 may be removed as described above, with a central portion of the
tube 20 being utilized as the drilling guide 40 for a tool 12 in
the form of a drill bit 48. Though FIG. 7 shows tube 20 as a drill
guide for a drill bit, it is understood that any other element
could also utilize the tube 20 as a guide. For example, a bone
screw could be positioned in the body using the tube 20 as a guide.
The tube 20 utilized as the drilling guide 40 may in some
embodiments be the same tube 20 in which the associated drill bit
48 is stored in the kit 10. The tube 20 may therefore have a
similar diameter to the diameter of the drill bit 48 such that
there is minimal play between the drill bit 48 and the drilling
guide 40. Alternatively, the tube utilized as the drilling guide 40
may be the tube 20 in which the element being positioned, such as
the screw, is stored in the kit, and having a diameter large enough
for the screw as well as to accommodate passage of a screwdriver
shaft therein. Referring back to the drilling guide 40 used for the
drill bit 48, the drilling guide 40 may be held at an orientation
relative to the patient such that the drill bit 48 passing through
the drilling guide 40 forms a hole 42 in the bone of the patient
along a desired trajectory thereby allowing for a good engagement
of a fastener into the bone, avoiding injury to adjacent soft
tissues, and avoiding contact with other hardware (e.g., fasteners,
plates, braces, etc.) in the vicinity of the hole 42. According to
an exemplary embodiment, the drilling guide 40 may be held in the
desired orientation by medical personnel via a handle 44. The
handle 44 may be provided as a part of the kit 10 and may be
removably coupled to the drilling guide 40 (e.g., via a threaded
connection, via a clamp, etc.). In other embodiments, the handle 44
may be a device such as a hemostat or other medical clamp. In other
exemplary embodiments, the drilling guide 40 may be held in the
desired orientation directly by the medical personnel or via a
stationary brace or fixture that is fixed in relation to the
patient.
Referring to FIG. 8, in one embodiment, the tube 20 may form a
sheath 60 that is coupled to a tool 12 that is in the form of a
bone screw 62. The sheath 60 may extend from one end of the screw
and provide a body for the medical personnel to grasp during the
procedure. A distal end 64 of the sheath 60 may be hollow to allow
access to the screw 62, such as to engage the head of the screw 62
with a screwdriver. The opening in the distal end 64 may be large
enough to accommodate the shaft of the screwdriver. The sheath 60
may remain coupled to the screw the entire medical procedure or a
portion of the medical procedure. For example, the sheath 60 may be
disposed in an incision through which the bone is accessed such
that it protects the surrounding tissues as the screw 62 is driven
into the bone. In some embodiments, all or a portion of the sheath
60 may remain coupled to the screw 62 after the procedure has been
completed. Such a sheath 60 may be treated to be antibacterial
(e.g., impregnated with antibiotic, silver or other antibacterial
materials).
Referring to FIGS. 9A-9B, the sheath 60 may have a variable
internal diameter. For example, the sheath 60 may include a first
portion 66 with a first inner diameter 67 and a second portion 68
with a second inner diameter 69. The first diameter 67 is greater
than the second diameter 69 and the sheath 60 is configured such
that a head portion 63 of the screw 62 can pass through the first
portion 66 but is prevented from passing through the second portion
68. In some exemplary uses, the screw 62 and the sheath 60 are
inserted into an incision proximate the bone to which the screw 62
will be coupled. The screw 62 is advanced into the bone until the
head 63 of the screw 62 is impeded by the second portion 68 of the
sheath 60. In this way, the length of a threaded portion 61 of the
screw 62 that extends outside of the sheath 60 is limited to a
desired length and the sheath 60 acts as a depth control device for
the screw 62. Accordingly, the length of the thickened portion
having the second inner diameter 69 may be configured with a length
according to the desired depth into the bone or the desired
distance that the screw, or other device, extends from the
sheath.
Referring now to FIGS. 10A-10B, in one embodiment, a tube 20 may
form a deformable sheath 70 and the tool, shown as a bone screw 72
contained within the sheath 70 may be utilized to open a closed end
74 of the sheath 70. The closed end 74 of the sheath 70 may be
formed, for example, by pinching or otherwise collapsing the sheath
70 such that the inner diameter prevents the screw 72 from
advancing out of the sheath 70 through the closed end 74 during
transport and handling of the sheath 70 or a kit containing the
sheath 70 prior to a medical procedure.
As shown in FIG. 10A, in one embodiment, the closed end 74 may be
completely closed. For example, the sheath 70 may be collapsed
inward and held together at the closed end with an adhesive, by
heat staking, or other appropriate process. In another embodiment,
the closed end 74 may not be completely closed and may instead have
an inner diameter that is sufficient to retain the screw 72 within
the sheath 70. For example, the sheath 70 may be formed with the
closed end 74 being formed by a tapered portion of the sheath 70.
The pinched or otherwise collapsed shape of the closed end 74
provides a tapered body that facilitates the insertion of the
sheath 70 and the screw 72 into an incision. As shown in FIG. 10B,
during a medical procedure, the screw 72 may be driven out of the
sheath 70 through the closed end 74. The closed end 74 is deformed
(e.g., forced open, spread apart, etc.) by the screw 72, allowing
the screw 72 to exit the sheath 70, pushing outward on the
surrounding tissue and protecting the surrounding tissue from the
screw 72.
Referring now to FIG. 11, in some embodiments, multiple tubes 20
and tools 12 may be nested to save additional space. A first tube
20A may be large enough in diameter to enclose a second tube 20B,
which may, in turn, enclose one or more tools 12B. The first tube
20A may enclose one or more tools 12A in addition to the second
tube 20B.
The tubes 20 and tools 12 are described above as being single-use
items that are provided as a kit 10 within the tray 14, pouch 16,
or other sterilized packaging. In other exemplary embodiments, the
tools 12 and the tubes 20 can be packaged and provided
individually, and not contained within a kit. In other exemplary
embodiments, the tubes 20 and the tools 12 contained within the
tubes 20 may be steam sterilized (e.g., using an autoclave) or
otherwise sterilized and may be provided separately from any
additional packaging. In other embodiments, the tubes 20 and/or the
tools 12 may be configured to be sterilized after use and
reused.
Further modifications and alternative embodiments of various
aspects of the invention will be apparent to those skilled in the
art in view of this description. Accordingly, this description is
to be construed as illustrative only. The construction and
arrangements of the bone screws and inserts, as shown in the
various exemplary embodiments, are illustrative only. Although only
a few embodiments have been described in detail in this disclosure,
many modifications are possible (e.g., variations in sizes,
dimensions, structures, shapes and proportions of the various
elements, values of parameters, mounting arrangements, use of
materials, colors, orientations, etc.) without materially departing
from the novel teachings and advantages of the subject matter
described herein. Some elements shown as integrally formed may be
constructed of multiple parts or elements, the position of elements
may be reversed or otherwise varied, and the nature or number of
discrete elements or positions may be altered or varied. The order
or sequence of any process, or method steps may be varied or
re-sequenced according to alternative embodiments. Other
substitutions, modifications, changes and omissions may also be
made in the design, operating conditions and arrangement of the
various exemplary embodiments without departing from the scope of
the present invention.
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